The Micra device is billed as the world's smallest pacemaker Medtronic is moving forward with studies on its own leadless pacemaker, the horse pill-sized Micra Transcatheter Pacing System that is only one-tenth the size of a standard pacemaker.
The Fridley, MN–based medical device giant recently announced that the device had been implanted in a human for the first time, with a patient in Linz, Austria receiving the device.
The news comes nearly two months after Little Canada, MN–based St. Jude Medical announced its $123.5 million acquisition of Nanostim, a Milpitas, CA–based company that has a AAA battery-sized device that won European Union approval.
When it comes to the Medtronic and Nanostim (now St. Jude) devices, both offer the ability to forgo running wires, called "leads" by the device designers, to the heart. Leads Leads can fracture, become dislodged, and cause other problems like infection.
And the devices are inserted inside the heart in a minimally invasive procedure, using a catheter.
Miniature electronics and catheter procedures appear to have reached a point together where the old method of running wires to the heart could become medical history.
"The combination of this novel technology with a transcatheter procedure can benefit patients by potentially reducing pocket or lead complications and recovery times observed with traditional surgical pacemaker implants," says Clemens Steinwender, MD, head of cardiology at the Linz General Hospital in Linz, Austria, of the Medtronic device.
For Medtronic, Micra TPS is an example of the significant investment the company is making in the miniaturization of implantable cardiac devices, says Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic.
"Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency. Through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world," Mackin says.
Medtronic's latest study of he device involves a single-arm, multi-center global clinical trial that will enroll up to 780 patients at approximately 50 centers, with initial results from the first 60 patients expected in the second half of 2014.
